Within the human body, bones are the solid organs that function to move, support, and protect other soft tissue organs in the body. When the human body is subjected to high force impact or stress, the effected bones may fracture. Sometimes, bones may even fracture under less demanding instances due to certain medical conditions (pathologic fractures), for example, Osteoporosis and Osteogenesis Imperfecta, weakening the bone system.
At other times, bones may heal in positions that are mechanically or functionally disadvantageous for normal or optimal functioning (malunions). In these situations, reconstructive surgery, during which bones are cut or “rebroken,” may be necessary to restore comfort and improve function.
Fractures of bones may be treated by a variety of methods including, for example, maintaining alignment with casts or splints (closed methods) or operative treatments (open methods). Open treatments for bone fracture may include bone fixation, i.e. open reduction internal fixation (ORIF), where the bone fragments are returned to their normal position for healing and maintained by internal devices and/or external immobilization. When a bone fracture occurs near a joint, i.e. a juxta-articular or peri-articular bone fracture, alignment of the fragments containing articular cartilage surfaces may be important to optimize short-term and long-term outcomes.
After alignment of fragments containing articular cartilage has been achieved, stabilization of the fragments to maintain anatomic alignment during the period of healing is advantageous. A typical bone fixation approach may include surgical implantation of a fastener, for example, a pin, a screw, or a peg, or a bone plate with a fastener construct. The typical bone plate and fastener construct may include an elongate portion with openings for receiving surgical screws or pegs for affixing the bone plate to a diaphysis of the fractured bone, and a flared head portion connected thereto with openings for receiving surgical screws for fixing the fractured portions in an epiphyseal or juxta-articular region of the fractured bone.
An approach to a bone plate is disclosed in U.S. Patent Application Publication No. 2007/0265629 to Martin et al. This bone plate is for treatment of a fracture of the distal portion of a radius bone, which is the bone of the forearm that extends from the lateral side of the elbow to the thumb side of the wrist. The bone plate includes a plurality of fastener openings and a central oblique linking area for aiding in proper placement of the bone plate.
Another approach to a bone plate is disclosed in U.S. Patent Application Publication No. 2006/0173458 to Forstein et al. This bone plate is for treatment of juxta-articular femur bone fractures. This bone plate includes an elongate member with openings for surgical screws, and a flared portion also with openings for surgical screws. This bone plate may be permanently contoured by the surgeon to more accurately fit the femur bone of the patient.
Yet another approach to a bone plate for bone fixation is disclosed in U.S. Pat. No. 7,326,212 to Huebner. This bone plate is also for treatment of distal radius bone fractures and includes an elongate member with openings for surgical screws, and a T-shaped head portion including openings for surgical screws and pivotally coupled to an end of the elongate member. Another distal radius bone plate is disclosed in U.S. Pat. No. 6,283,969 to Grusin et al. This bone plate includes an extender for mating to the flared head portion of the bone plate.
Another approach to a distal radius bone plate is disclosed in U.S. Patent Application Publication No. 2007/0083202 to Eli Running et al. This bone plate includes sheaths for covering the surgical screw heads received by the flared head portion of the bone plate. Each sheath has an opening for receiving a screw for securing the sheath to the bone plate.
Potential drawbacks to the disclosed bone plates are: a lack of cost effectiveness, complexity of implantation, and limitations of the bone plate to engage certain fragments because of the predetermined morphology of the manufactured plate. More particularly, some bone plating systems may use a large inventory of parts for customization to the patient's native anatomy. This may be problematic for cost sensitive environments, for example, in ambulatory surgery centers (ASC) and other outpatient health care facilities in the United States and abroad.